Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00369564 · FLOW

Participant flow

Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients With Cancer · Source last updated 2021-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a total of 1500 mg/day of oral glutamic acid .
    id
    FG000
    title
    Arm I Glutamic Acid
  2. description
    Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent. Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). .
    id
    FG001
    title
    Arm II Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        123
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        84
      2. group Id
        FG001
        num Subjects
        100
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        23
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a total of 1500 mg/day of oral glutamic acid .
    id
    FG000
    title
    Arm I Glutamic Acid
  2. description
    Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent. Patients with a body surface area (BSA) less than 1.0 m\^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m\^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). .
    id
    FG001
    title
    Arm II Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        123
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        84
      2. group Id
        FG001
        num Subjects
        100
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        23
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice